CORONA, Calif., Sept. 13 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has reached a settlement with Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., and Laboratories Besins Iscovesco on outstanding patent litigation related to AndroGel(R) 1% (testosterone gel) CIII, a topical testosterone replacement gel.
In May 2003, Watson submitted an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of AndroGel. Watson received final approval of its ANDA on January 27, 2006 and was awarded 180 days of marketing exclusivity for its ANDA.
Under terms of the settlement agreement, Solvay Pharmaceuticals has granted Watson a non-exclusive license to the U.S. patents covering AndroGel. Watson has agreed not to commence marketing its generic equivalent product until August 31, 2015 or the date on which another generic product enters the U.S. market, whichever occurs first. Additionally, Watson has agreed to forfeit its 180-day marketing exclusivity on the product awarded under the Hatch-Waxman Act.
Commenting on the settlement, Dr. Allen Chao, Watson's Chairman and CEO, said, "I am pleased that we have been able to settle the patent litigation with Solvay Pharmaceuticals. We are able to get a generic product to market five years earlier than the last-to-expire patent -- a win for both patients and Watson. Additionally, we resolve the uncertainty of the outcome of the litigation and prevent the lawsuit from becoming a more costly and time consuming dispute."
In a separate agreement, effective October 1, 2006, Watson and Solvay Pharmaceuticals have agreed that Watson's Specialty Products sales force will co-promote AndroGel to urologists in the United States.
"Watson has a very strong reputation with urologists, and AndroGel will be a nice complement to our growing portfolio of urology products. It will enhance our relationships with those physicians as we continue to build our presence in this area," Dr. Chao said.
About AndroGel(R)
Hypogonadism, also known as low testosterone (low T), is one of the top 10 most prevalent conditions seen by urologists. In fact, it is estimated that low T affects up to 13 million American men aged 45 years and older.
AndroGel is the number one prescribed form of testosterone therapy in the United States. AndroGel is a once-daily, clear, odorless, topical testosterone gel indicated for replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone. Symptoms of low T may include low sex drive, erectile dysfunction, fatigue, depressed mood, reduced muscle mass and strength, increased fat body mass and decreased bone mineral density. Testosterone treatment is designed to help elevate a hypogonadal man's testosterone levels into the normal range and alleviate symptoms.
Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. AndroGel is not indicated for use in women, has not been evaluated in women, and must not be used in women. Geriatric patients treated with androgens may be at an increased risk for the development of enlarged prostate and prostate cancer. Please refer to the AndroGel prescribing information for complete safety information.
Information about AndroGel may be found online at: http://www.androgel.com/.
Forward-Looking Statement
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the difficulty of predicting the timing and outcome of litigation; risks that resolution of patent infringement litigation through settlement could result in investigations or actions by private parties or government authorities; the impact of competitive products and pricing; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2005 and Form 10-Q for the period ended June 30, 2006.
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